Recall Record

South Plainfield, NJ, United States

HANDELNINE GLOBAL LLC recalls

1 recall recorded since 2018, most recently on 22 December 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)1

Ongoing Class I Drugs

Recall started
22 December 2025
Reason
CGMP Deviations: product found to contain lead.
Distribution
Product was distributed to one customer in NY.
Initiated
Voluntary: Firm initiated
Recall number
D-0332-2026

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.